PatientsLikeMe believes that through their data modeling techniques, they can "determine the significance of each reported
change in each patient as he/she deviates from his/her predicted course." The results will likely be reported on the Web site
with the same quality of graphics and display found elsewhere on the site and will appear to be a critical look at this question
with eight times as many patients as were enrolled in the originally reported clinical trial. Aside from data quality and placebo effect issues (which they do take seriously), the bias from openly available data is enormous,
and the potential for incorrectly concluding that a possibly ineffective and toxic drug is effective is very high. In addition,
these activities could potentially starve active clinical trials from recruiting the needed patients to complete their blinded
analysis of the same problem. Another concern will emerge as participants in PatientsLikeMe begin to enter conventional clinical trials. There open reporting
of their experiences with study medications, along with any adverse experiences they encounter, would likely be available
individually and possibly in aggregate on the site. Again, in tightly affiliated patient communities, this could lead to bias
and even unblinding of conventional clinical trials. While these concerns aren't anywhere near the evils of Pandora's jar, they certainly have the potential to create some major
headaches in the halls of biopharmaceutical companies in the foreseeable future. To their credit, the company has been proactive in engaging pharmaceutical companies about some of these concerns. Hope Remains As in the Pandora story, there is certainly reason to be hopeful about the value of communities like PatientsLikeMe. As they
are compelling for patients, they may become a major center of gravity for some disease communities, especially if they align
with officially recognized patient advocacy groups. In the Web 1.0 world, we might have thought of these as sources for improving patient recruitment in clinical trials—in the
past, a model that has been less than stellar in accomplishing this goal. Instead, we should think of them as potential registries
of patients, which are possibly available for improving our understanding of the biopsychosocial aspects of disease, and disease
therapies. They might be used to generate hypotheses, follow patients in naturalistic settings, and even test some ideas in
a more structured fashion. Technology is here to stay, and it will bring changes in communication and interactivity that we can't even anticipate, along
with many opportunities and some risk. Much as we would like to, we can't stop Pandora from opening that jar; we can only
try to maximize our benefit from the hope that remains. Paul Bleicher MD, PhD, is the founder and chairman of Phase Forward, 880 Winter Street, Waltham, MA 02451, (888) 703-1122, paul.bleicher@phaseforward.com
http://www.phaseforward.com/. He is a member of the Applied Clinical Trials Editorial Advisory Board.
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